Dialyzer Optiflux 160NRe recalled for potential internal blood leaks from cracked polyurethane
Fresenius Medical Care is recalling Dialyzer Optiflux 160NRe units nationwide due to potential internal blood leaks caused by cracked polyurethane in the dialyzer material.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall for a risk-of-harm product (dialyzer for critical clinical use) with potential for internal blood leaks due to cracked polyurethane. No reported illnesses or injuries are mentioned in the source material.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Dialyzer Optiflux 160NRe units distributed nationwide. The recall includes 5,351 cases containing 64,212 dialyzers with UDI numbers 24HU06011-00840861100149-270630 and 24HU06010-00840861100149-270630 (expiration date: 06/30/2027).
These dialyzers may develop cracks in the polyurethane material, which could result in internal blood leaks. This poses a safety risk.
Healthcare facilities with affected units should discontinue use and contact Fresenius Medical Care Holdings, Inc. for replacement or return instructions. Patients should consult with their healthcare providers regarding their medical equipment.
For additional information, contact Fresenius Medical Care Holdings, Inc.
The recalled product
- Product
- Dialyzer Optiflux 160NRe
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI NUMBERS: 24HU06011-00840861100149-270630
- 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
Distribution
Distributed nationwide across the United States.
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